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64
Warning to Hearing Aid Dispensers
A hearing aid dispenser should advise a prospective
hearing aid user to consult promptly with a licensed
physician (preferably an ear specialist) before dispensing
a hearing aid if the hearing aid dispenser determines
through inquiry, actual observation, or review of any
other available information concerning the prospective
user, that the prospective user has any of the following
conditions:
(i) Visible congenital or traumatic deformity of the ear.
(ii) History of active drainage from the ear within the
previous 90 days.
(iii) History of sudden or rapidly progressive hearing
loss within the previous 90 days.
(iv) Acute or chronic dizziness.
20. For the US market only, complies
with the FDA regulations
Important Notice for Prospective Hearing Aid Users
Good health practice requires that a person with a
hearing loss have a medical evaluation by a licensed
physician (preferably a physician who specializes in
diseases of the ear) before purchasing a hearing aid.
(v) Unilateral hearing loss of sudden or recent onset
within the previous 90 days.
(vi) Audiometric air-bone gap equal to or greater than
15 decibels at 500 hertz (Hz), 1,000 Hz, and 2,000 Hz.
(vii) Visible evidence of significant cerumen
accumulation or a foreign body in the ear canal.
(viii) Pain or discomfort in the ear. Special care should be
exercised in selecting and fitting a hearing aid whose
maximum sound pressure level exceeds 132 decibels
because there may be risk of impairing the remaining
hearing of the hearing aid user. (This provision is
required only for those hearing aids with a maximum
sound pressure capability greater than 132 decibels
(dB).)
Summary of Contents for Sky V 50
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